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Safety Study of TRK-820 for Patient With Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
Toray Industries, Inc
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01248650
First received: November 23, 2010
Last updated: November 24, 2010
Last verified: November 2009
History of Changes
  Purpose

The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.


Condition Intervention Phase
Chronic Renal Failure
 Drug: nalfurafine hydrochloride
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by SK Chemicals Co.,Ltd.:

Enrollment: 16
Study Start Date: December 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TRK-820 5 μg
Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route
 Drug: nalfurafine hydrochloride
Active Comparator: TRK-820 2.5μg
Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route
 Drug: nalfurafine hydrochloride

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
  • Patients aged 20 years or older
  • Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 ~ 130 %
  • Patients who can understand and follow instructions and participate in the study during the entire study period
  • Patients who signed the informed consent form before participating in the study

Exclusion Criteria:

  • Patients who have confirmed malignant tumor
  • Patients with cognitive impairment including depression, schizophrenia and dementia
  • Patients with hepatic cirrhosis as a complication
  • Patients with drug allergy to opioids
  • Patients with drug dependency or allergic disease (including skin response to UV radiation)
  • Patients who participated in other study and received the investigational drug within 1 month before the signing day
  • Patients who participated in other TRK-820 study within 4 weeks before the signing day
  • Pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception

  • Patients who received any of the following drugs within 2 weeks before Day 1

    1. Azole antifungal agents

      1. Ketoconazole
      2. Fluconazole
      3. Itraconazole
      4. Clotrimazole

    2. Macrolide antibiotics

      1. Erythromycin
      2. Midecamycin
      3. Josamycin
      4. Roxithromycin
      5. Clarithromycin
      6. Triacetyloleandomycin
    3. Ritonavir
    4. Cyclosporine
    5. Nifedipine
    6. Cimetidine
    7. Amiodarone

  • Patients who had the following drinks and foods within 2 weeks before Day 1

    1. Foods and drinks containing grape fruit juice
    2. Food and drinks containing St. John's wort
  • Patients who participated in other clinical study during the period between the singing day and hospitalization (Day 1)
  • Patients who smoked and drank from three months before the signing day
  • Patients who are ineligible for the clinical study for other reasons at the investigator's discretion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248650

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Toray Industries, Inc
Investigators
Principal Investigator: Wooseong Huh, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Hogan Park, SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01248650     History of Changes
Other Study ID Numbers: TRK-820_HD_I_2008
Study First Received: November 23, 2010
Last Updated: November 24, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by SK Chemicals Co.,Ltd.:
Safety evaluation
Pharmacokinetic analysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013